Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets, usp are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to th

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

covis pharma us, inc - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - rilutek is indicated for the treatment of amyotrophic lateral sclerosis (als). rilutek is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)] . there are no studies of rilutek in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated with use of rilutek durin

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

apotex corp - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)]. risk summary there are no studies of riluzole tablets in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole 50 mg - riluzole tablets are indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets are contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of their components (anaphylaxis has occurred) [see adverse reactions (6.1)]. there are no studies of riluzole tablets in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associa

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

quinn pharmaceuticals, llc - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole tablets, usp is indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)] . there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associ

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

aquestive therapeutics - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - exservan is indicated for the treatment of amyotrophic lateral sclerosis (als). exservan is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions ( 6.1 )] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2­ 4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated with us

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

quinn pharmaceuticals - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions ( 6.1)] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, wome

Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

mitsubishi tanabe pharma america, inc. - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - exservan is indicated for the treatment of amyotrophic lateral sclerosis (als). exservan is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)] . there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2‑ 4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associated with use of exservan d

Izraēla - angļu - Ministry of Health

novartis israel ltd - octreotide - powder and solvent for suspension for injection - octreotide 30 mg - octreotide - octreotide - treatment of acromegaly in: patients already adequately controlled on standard doses of sandostatin s.c. patients in whom surgery or radiotherapy are inappropriate or ineffective, or who are in the latency period before radiotherapy becomes fully effective.endocrine gastro-entero- pancreatic (gep) tumors, carcinoid tumors.

Izraēla - angļu - Ministry of Health

novartis israel ltd - octreotide - powder and solvent for suspension for injection - octreotide 20 mg - octreotide - octreotide - treatment of acromegaly in: patients already adequately controlled on standard doses of sandostatin s.c. patients in whom surgery or radiotherapy are inappropriate or ineffective, or who are in the latency period before radiotherapy becomes fully effective. endocrine gastro-entero- pancreatic (gep) tumors, carcinoid tumors.